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Cephalon modafinil "approvable" in ADHD

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Cephalon is anticipating an early 2006 approval of Sparlon (modafinil, formerly Attenace) for attention deficit/hyperactivity disorder, the firm says Oct. 21. FDA deemed the agent "approvable" Oct. 20 for use in children and adolescents ages six to 17 years. The Sparlon NDA is based on three seven- to nine-week pivotal trials showing "significant improvement compared to placebo as early as the first week, with continued improvement during titration and dose maintenance," Cephalon says. The company announced an agreement in August to co-promote Sparlon with Johnson & Johnson's McNeil Consumer & Specialty Pharmaceuticals Division (1Pharmaceutical Approvals Monthly September 2005, p. 24)...
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